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FDA 510(k)

MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES

K-Number: K040176 · 2004-02-24

ApplicantMaxter Glove Manufacturing Sdn Bhd
Decision Date2004-02-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2004-02-24 under 510(k) number K040176. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES?

MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-02-24. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. The 510(k) number is K040176.

When did MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES receive FDA 510(k) clearance?

MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES received FDA 510(k) clearance on 2004-02-24, under 510(k) number K040176.

Who is the listed applicant for MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES?

The FDA 510(k) record lists Maxter Glove Manufacturing Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES?

The FDA product code for MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES is LZA.

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Other records listing Maxter Glove Manufacturing Sdn Bhd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsK151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsK113100POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSK032501MAXTER STERILE POWDER FREE SURGICAL GLOVESK032467MAXTER STERILE POWDERED LATEX SURGICAL GLOVESK013498CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

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Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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